ACRP-PM cheat sheet

A project is a temporary endeavor with a defined start and end, producing a unique deliverable; operations are ongoing and repetitive.

The triple constraint: scope, time, and cost are interdependent; a change to one forces adjustment in at least one other.

PMBOK process groups: Initiating, Planning, Executing, Monitoring and Controlling, Closing; they recur across phases.

A study phase (e.g., Phase I to Phase II) is a lifecycle stage; a project is the whole temporary endeavor, which may span multiple phases.

GxP documentation is a controlled deliverable: any change to an approved document requires version control and audit trail.

Progressive elaboration: study plans are refined iteratively as knowledge increases; early estimates carry wider ranges.

A deliverable is any measurable, verifiable outcome (protocol, CRF, monitoring report, CSR); milestones are zero-duration checkpoints.

Knowledge areas map to domains: integration, scope, schedule, cost, quality, resources, communications, risk, procurement, stakeholders.

Scope baseline = approved scope statement + WBS + WBS dictionary; scope creep is uncontrolled change without approved change control.

WBS decomposes deliverables into work packages; the lowest level should be estimable and assignable to one owner.

Critical path = longest duration path through the network; it determines minimum project duration and has zero float.

Float (slack) = late start minus early start; total float is shared along a path, free float is unique to an activity.

Schedule compression: crashing adds resources/cost to shorten duration; fast-tracking overlaps activities and increases risk.

Milestones have zero duration and mark completion of a key deliverable (e.g., first patient in, database lock).

Dependencies: finish-to-start is most common; mandatory dependencies are contract/regulatory, discretionary are preferred sequencing.

Rolling wave planning details near-term work while later work remains at a higher level until more is known.

Schedule baseline is the approved version; performance is measured against it, and changes require formal approval.

Per-patient cost = (total study cost − fixed costs) ÷ planned enrollment; useful for change-order pricing.

Earned value: EV = % complete × BAC; PV = planned value; AC = actual cost.

Cost variance CV = EV − AC (positive is under budget); schedule variance SV = EV − PV (positive is ahead of schedule).

CPI = EV ÷ AC; SPI = EV ÷ PV; values below 1.0 indicate over cost or behind schedule.

EAC = BAC ÷ CPI when current cost performance is expected to continue; ETC = EAC − AC.

Resource leveling changes start/finish dates to resolve over-allocation; resource smoothing adjusts within float without changing the critical path.

Vendor selection uses weighted scoring against predefined criteria; a statement of work defines deliverables, timeline, and acceptance criteria.

Contract types: fixed-price shifts cost risk to vendor; time-and-materials and cost-reimbursable shift more risk to the sponsor.

Budget categories in clinical trials: pass-through costs (per-patient, per-visit) versus non-pass-through (start-up, close-out) fees.

Risk is an uncertain event that, if it occurs, affects objectives; an issue is a risk that has already occurred and requires action.

Risk register fields: ID, description, cause, potential effect, probability, impact, score, response, owner, status.

Risk score = probability × impact; thresholds define which risks require escalation or a formal response plan.

Negative risk responses: avoid, transfer, mitigate, accept; positive (opportunity) responses: exploit, share, enhance, accept.

Risk triggers are warning signs that a risk is about to occur; residual risk remains after response, secondary risk arises from the response.

Quality assurance is process-focused (preventive); quality control is product-focused (inspection, detection).

Plan-Do-Check-Act (Deming cycle) underpins continuous quality improvement in clinical operations.

Issue log tracks owner, description, priority, due date, and resolution status; escalation paths should be pre-defined.

Root cause analysis tools: 5 Whys and fishbone (Ishikawa) diagrams distinguish symptom from underlying cause.

Stakeholder power/interest grid: high power-high interest = manage closely; low power-low interest = monitor.

Communication plan defines who receives what information, in what format, frequency, and through which channel.

Communication channel count = n(n − 1) ÷ 2, where n is the number of stakeholders; complexity grows rapidly with team size.

Tuckman team stages: forming, storming, norming, performing, adjourning.

Conflict resolution modes: collaborating (win-win), compromising, accommodating, competing, avoiding; collaborating is preferred for important issues.

RACI matrix assigns roles: Responsible (does work), Accountable (one per task, approves), Consulted (two-way input), Informed (one-way updates).

Leadership styles: directing (low competence/high commitment), coaching, supporting, delegating (high competence/high commitment).

Status reports are push communication for routine updates; lessons learned capture is a closing process for the whole project.

Escalation should follow the defined chain and be triggered by thresholds, not emotion; document the issue and decision.